Saw Palmetto (cont.)
Not many studies have been performed comparing saw palmetto and a-
adrenergic blocking agents, the other conventional drugs used in the
treatment of BPH symptoms. In a small, double-blind study comparing
saw palmetto with prazosin in 41 patients for three months, prazosin
was found to have slightly greater effect on urine flow rate,
nighttime urination, and amount of urine remaining in the bladder
after voiding than saw palmetto. Studies comparing the effect of saw
palmetto to that of surgery for symptoms of BPH have not been
performed.
How does saw palmetto work?
The way in which saw palmetto works to relieve the urinary symptoms
of BPH is unclear. Laboratory studies suggest that the extract of
saw palmetto blocks the conversion of testosterone to its more active
potent form, in the same way that the conventional drug finasteride
does. However, studies in humans have not been able to confirm a
significant reduction in activated testosterone. Other proposed
mechanisms of action of saw palmetto include interference with the
action of activated testosterone on prostate cells, as well as an
anti-inflammatory effect.
What are the adverse effects of saw palmetto?
Adverse effects of saw palmetto are rare. They include headache,
nausea, and upset stomach and are comparable in frequency to the
symptoms experienced by the group taking the placebo. Erectile
dysfunction has not been commonly reported among patients taking saw
palmetto. It has been reported in 1.1% of men taking saw palmetto,
0.7% of men taking placebo, and 4.9% of men taking finasteride. The
percent of men with erectile dysfunction after surgery for BPH is not
clear. In one study, approximately 28% of men subjectively reported
a decrease in the quality of erection after surgery; however, no
worsening of objective parameters of erectile function were found.
Although no drug interactions with saw palmetto have been
systematically sought, no such interactions have been documented to
date.
Is saw palmetto officially approved for use in BPH?
While saw palmetto is not officially approved in the United States
for the treatment of urinary symptoms from BPH, it has been approved
for this use in Germany. The German government assigned a commission
in 1978 to oversee the efficacy and safety of herbal agents. The
commission (German Commission E) reviews data from clinical trials
and case reports, and considers opinions that they determine have
merit.
What other concerns relate to using saw palmetto?
While the results of the trials are encouraging, the response from a
product purchased from your local nutritional supplement store is not
always predictable. This is because saw palmetto products are not
standardized in terms of dosages or preparations. Even the available
clinical studies used different doses and preparations of saw
palmetto. The most common dose used in these studies was 160 mg
twice per day. Since long term studies are not available, the
incidence of adverse effects from the chronic use of saw palmetto
extract has yet to be determined. Knowing adverse effects of the
chronic use of saw palmetto is important because BPH is a chronic
condition that requires continuous treatment indefinitely.
General information about saw palmetto
As a dietary supplement, saw palmetto cannot be claimed by its
manufacturers to treat or prevent disease. Dietary supplements are
regulated under the 1994 Dietary Supplement Health and Education Act,
which does not demand particular testing procedures for the safety or
effectiveness of these products before they are brought to market.
Since they are not considered drugs under regulation by the Food and
Drug Administration, prescriptions are not needed to obtain them in
the United States.
What about the future of saw palmetto?
To establish the use of saw palmetto in the management of BPH,
additional well designed studies are needed. Clinical trials must
compare the efficacy and adverse effects of saw palmetto directly
with those of the conventional medical and surgical treatments for
BPH. We especially need data on the safety of ingesting this herb
for the long term. Meanwhile, information should be obtained on what
the active ingredient is in saw palmetto, and how it works in
treating BPH.
Saw Palmetto At A Glance
- Saw palmetto is an herbal treatment for symptoms of benign prostatic
hypertrophy (BPH) such as hesitancy, urgency, dribbling, increased
frequency in urinating, and increased nighttime urination.
- Saw palmetto is comparable in effectiveness to conventional
medication in the treatment of urinary symptoms associated with BPH.
- Short term use of saw palmetto has fewer adverse effects than
conventional medications for BPH.
- The incidence of adverse effects from long term use of saw
palmetto is unknown, and long term treatment is needed for BPH.
Reference: FDA Prescribing Information
Last Editorial Review: 11/30/1999 8:21:00 PM
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
- Drug Interactions - Learn about potential drug interactions you may be exposed to. Drug interactions can occur with prescription drugs, OTC medication, vitamins, herbs, and supplements.
- Benign Prostatic Hyperplasia - Get the facts on benign prostatic hyperplasia symptoms and prevention of an enlarged prostate gland. BPH treatment may involve medication or surgery. BPH is not cancer.
- Drugs: What You Should Know About Your Drugs - Find out what you should know about your drugs such as side effects, warnings and precautions, storage information, and if a generic version is as good as the brand name.
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